Fax sent:
Dear Darren,
I am a shareholder in Clinuvel and will be attending the AGM tomorrow morning.
I propose to ask the following questions, if they aren’t addressed in the main presentation:
1. The 2008 annual report noted that Phase III interim results were expected in the first quarter of 2009. We still have not been presented with the results. Could you provide an update as to the status?
2. At the last AGM a lot of time was given to the potential for afamelanotide in PDT. In particular, US trials were supposed to have started early this year. However, we have heard very little on this indication recently. Could you provide an update as to progress?
3. Could you provide an update as to the relocation of the US office? Again, this was originally planned for earlier this year.
4. The timeline presented in the 2008 report (on the page “Communicating Signposts”) implies that we should have received by now:
- Interim results for EPP and PLE Phase III (due 1Q 09)
- Interim results for AK/SCC Phase II (due 3Q 09)
- Full results for AK/SCC Phase II (due 3Q 09)
- First results for PDT Phase II trials (due 2Q 09)
The 2008 AGM presentation also says that we should have a trade name for Afamelanotide by now, as well as the start of a pediatric trial.
Apart from interim results for EPP, none of these have been delivered.
5. It was announced with much fanfare earlier this year that we would be applying for MAA with the EMEA by the end of the year. We have now heard that instead of filing this year, you’ll merely be deciding when to file next year. Why did you say that you were going to file when clearly you couldn’t?
6. I note that Phillipe received an increase in base salary from ~$400k to ~$600k from 2008 to 2009. What is the justification for this raise, particularly given that very few of the above milestones have been met?
7. How do you expect us to believe any new timeline when you met very few of the milestones you forecast for last year?
Regards,
[someone else]
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